Remediation of Emotional Processing Deficits in MS

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT03373344
• Lead Sponsor: Kessler Foundation

Brief Summary

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well

Detailed Description

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.

All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-12-08
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-14
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• between the ages of 18-65.
• diagnosis of Relapsing-Remitting Multiple Sclerosis.
• can read and speak English fluently.

Exclusion Criteria

• history of prior stroke or other neurological disease or injury.
• history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder.
• significant alcohol or drug abuse history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Emotional Processing	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)	Change in scores on computerized tests of emotional processing

Secondary Outcome Measures

Name	Time	Method
Self report of Quality of Life	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)	Change in scores on self-report of quality of life, measured via questionnaire
Emotional Function	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)	Change in scores on self-report of emotional functioning, measured via questionnaire

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States